Accolade Pacemakers Recalled for Hydrogen-Related Battery Depletion
Boston Scientific is recalling Accolade pacemaker models L300, L301, L310, L311, L321, and L331 due to latent hydrogen release that compromises the capacitor and accelerates battery depletion.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a life-critical device with a defect that could lead to premature device failure. No injuries or hospitalizations reported, but pacemakers are inherently risk-of-harm products where any malfunction is serious, fitting the High severity criterion: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Boston Scientific Corporation is recalling the Accolade pacemaker in models L300, L301, L310, L311, L321, and L331. Approximately 70,074 units were distributed worldwide.
The recall addresses a defect in which latent hydrogen may accumulate within the pacemaker, potentially causing the low voltage capacitor to become electrically compromised. This compromise can result in accelerated battery depletion and faster progression of the displayed battery status indicators.
No injuries or illnesses have been reported in connection with this defect. Patients with these pacemaker models should consult their healthcare provider regarding their specific device.
The recalled product
- Product
- Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 70,074
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) L300
- Serial Numbers: 712118
- 713277
- 713352
- 713357
- 713365
- 713381
- 713390
- 713398
- 713403
- 713405
- 713406
- 713420
- 713440
- 713443
- 713447
- 713454
- 713456
- 713459
- 713461
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Similar recalls
- SevereBoston Scientific Recalls ACCOLADE Pacemakers Due to Battery Depletion Risk
FDA (Devices) · 2018-10-03
- SevereACCOLADE DR Pacemakers Recalled for Unintended Safety Mode Activation
FDA (Devices) · 2025-01-22
- SevereBoston Scientific Recalls PROPONENT Pacemakers Due to Battery Depletion
FDA (Devices) · 2018-10-03
- CriticalACCOLADE dual chamber standard life pacemakers recalled for software update
FDA (Devices) · 2025-10-22
- HighBoston Scientific Recalls ACCOLADE DR Pacemakers Due to Sensor Issues
FDA (Devices) · 2018-01-24
- CriticalACCOLADE single chamber standard life pacemakers recalled for software update
FDA (Devices) · 2025-10-22